The addition of daratumumab to standard-of-care regimens used to treat multiple myeloma, such as bortezomib, melphalan, and prednisone, decreased the risk of disease progression or death in newly diagnosed patients who were ineligible for autologous stem-cell transplantation.
Adding daratumumab to standard-of-care regimens used to treat multiple myeloma decreased risk of disease progression or death in newly diagnosed patients, according to new research.
In a new study published in New England Journal of Medicine, researchers report an interim analysis of ALCYONE, a randomized phase 3 trial of bortezomib, melphalan, and prednisone with or without daratumumab in patients with newly diagnosed multiple myeloma. Patients were between the ages of 40 and 93, and were ineligible for autologous stem-cell transplantation.
“The risk of multiple myeloma increases with age, and despite progress in the development of effective treatment, the disease remains incurable,” the authors explained. The most widely approved regimens, which include bortezomib, melphalan, and prednisone outside of the United States, “are associated with a progression-free survival of 18 months to 2 years and an overall survival of 4 to 5 years.”
The 706 patients were either assigned to the daratumumab group (n = 350) or the control group without daratumumab (n = 356). Ultimately, 79.8% of patients in the daratumumab group and 62.1% of patients in the control group completed all 9 cycles of the regimen by the clinical cutoff date. After the 9 cycles, patients in the control group discontinued treatment, while patients in the daratumumab group continued daratumumab as a monotherapy.
At the clinical cutoff date, disease progression or death had occurred in 25.1% of patients in the daratumumab group compared with 40.2% of patients in the control group. The median progression-free survival in the control group was 18.1 months and had not been reached in the daratumumab group.
The researchers found that “combining daratumumab with bortezomib, melphalan, and prednisone did not increase overall toxicity.” Adverse events were balanced between the 2 groups. The only exception was the rate of grade 3 or 4 infections, which was higher in the daratumumab group compared with the control group (23.1% versus 14.7%).
“Overall, daratumumab in combination with this standard-of-care regimen was associated with infusion-related reactions and more infections, including a higher rate of pneumonia (which did not result in higher rates of discontinuation or death); the usual chemotherapy-related toxic effects were not increased by the addition of daratumumab,” the authors concluded.
Mateos MV, Dimopoulos MA, Cavo M, et al. Daratumumab plus bortezomib, melphalan, and prednisone for untreated myeloma. N Engl J Med. 2018;378:518-28. doi: 10.1056/NEJMoa1714678